Kornimate/medical-research-clean huggingface dataset:
long term effectiveness and safety study for rwj-333369 as adjunctive therapy in korean and japanese patients with partial onset seizures

Conditions: Seizures

Summary: the purpose of this study is to evaluate the long-term safety of rwj-333369 at doses between 200-800 mg/day in korean and japanese patients who have completed the preceding study (333369-kj-02).

despite the introduction of new antiepileptic drugs into overseas clinical settings after 1990's, there still exist those patients who cannot control seizures, and thus the advent of newer antiepileptic drugs is being desired. this is a multicenter, open-label, extension study in patients who have completed the preceding study (333369-kj-02) and scheduled to continue until the study drug is approved. this study consists of period 1 (1 year) and period 2 (only in japan; planned to continue until the drug is approved primary objective of this study is to evaluate the long-term safety (adverse event, lab test, electrocardiogram, vital signs, pregnancy test, physician withdrawal checklist) of rwj-333369 at doses between 200-800 mg/day in patients who have completed the preceding study. secondary objective of this study is to evaluate the long-term effectiveness of rwj-333369 at doses between 200-800 mg/day in patients who have completed the preceding study. period 1:rwj-333369 will be started at 400 mg/day. rwj-333369 100 mg tablets or 200 mg tablets will be orally administered with noncarbonated water twice daily. the dose will be adjusted between 200 mg/day and 800 mg/day based on effectiveness and tolerance. period 2: the dose will be adjusted between 200 mg/day and 800 mg/day based on effectiveness and tolerance.

Eligibility criteria:
inclusion criteria: * patients in the preceding study (333369-kj-02) who have completed double-blind treatment phase of preceding study exclusion criteria: * considered ineligible as study patients by the investigator

Keywords: partial onset seizure adjunctive therapy
ikervis for ded due to gvhd post allo-hsct

Conditions: Leukemia (Both ALL and AML); MDS-EB-1

Summary: dry eye disease (ded) is a common sequelae of graft versus host disease (gvhd) after allogeneic hematopoietic stem cell transplantation (allo-hsct). since ikervis is reported to be a safe and efficacious treatment of ded associated with chronic gvhd, our study would like to study the efficacy of prophlactic ikervis in preventing ocular gvhd development.

this is a prospective single arm interventional study. the recruitment period will be over 12-18 months to enroll all suitable patients. the total duration of prophylaxis will be for 1 year. after completion of the period of prophylaxis, the patients will be followed up as a non-study patient as clinically indicated. forty subjects, undergoing allo-hsct, will be recruited from the singapore national eye centre upon referral from the department of hematology, singapore general hospital and followed up at least 5 times over a period of 12 months at the singapore eye research institute. the images of the subject eyes will be recorded and stored electronically. these images (corneal fluorescein staining score, lipiview, meibography, conjunctival redness, tear stability assessment) will be used in the analysis of outcome measures. the lipiview result is in video format.

Eligibility criteria:
inclusion criteria: * age 13 and above * able to give informed consent exclusion criteria: * presence of concurrent disease * unable to complete the follow up
an investigational study of mk0928 in adult outpatients with insomnia (0928-014)(completed)

Conditions: Insomnia

Summary: the purpose of this study is to evaluate the safety and effectiveness of mk0928 for insomnia (a sleep disorder).


Eligibility criteria:
inclusion criteria: * adult outpatients who are between the ages of 18 and 64 exclusion criteria: * adults who do not have a diagnosis of insomnia (a sleep disorder)
enhanced genetic awareness and genetic evaluation for men through technology, engagement study

Conditions: Prostate Carcinoma

Summary: this study assesses perceived usefulness of a web-based virtual prostate cancer genetics board for providers across academic, community, and veteran affairs settings to discuss prostate cancer genetics cases, precision treatment, and screening recommendation. information gained from interviews and surveys of participants taking part in the virtual genetics board may lend insights into perceived usefulness, perceived ease of use, acceptability, self-efficacy, genetics knowledge, and barriers/facilitators to implementation to refine the process.

primary objective: i. to assess perceived usefulness of a virtual genetics board. secondary objective: i. to assess acceptability/feasibility, perceived ease of use, self-efficacy for recommendations, genetics knowledge. outline: participants complete a survey about genetic knowledge and self efficacy and then attend virtual genetics board. after virtual genetics board meeting, participants complete a second survey about perceived usefulness, ease of use, acceptability, feasibility, self-efficacy and genetic knowledge. participants may also complete a semi-structured interview after virtual genetics board.

Eligibility criteria:
inclusion criteria: • non-genetic providers who perform pca genetic testing for men in their practices (medical oncologists, radiation oncologists, urologists, primary care providers, mid-level providers) exclusion criteria: • non-medical providers
pilot study of short-course preoperative stereotactic body radiation therapy for resectable pancreatic cancer

Conditions: Pancreatic Cancer; Adenocarcinoma

Summary: the purpose of this study is to determine whether a short-course of stereotactic body radiotherapy (sbrt) prior to surgical resection of pancreatic adenocarcinoma is feasible and well-tolerated.

this will be a phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (sbrt) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.

Eligibility criteria:
inclusion criteria: 1. patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas 2. ct w/ contrast using the pancreas protocol or mri of the abdomen with contrast within 6 weeks prior to registration 3. ct chest or pet/ct within 6 weeks prior to registration 4. clinically determined to be resectable based on nccn criteria: 5. no radiographic evidence of superior mesenteric vein or portal vein distortion 6. no evidence of distant metastasis 7. clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery 8. no enlarged lymph nodes per ct criteria or pet avid lymph nodes 9. no lymphadenopathy outside the surgical field (i.e. celiac or para-aortic adenopathy) 10. adequate cardiopulmonary reserves to tolerate surgery 11. karnofsky performance status \> 70 12. age \>18 13. adequate bone marrow function defined as follows: 14. absolute neutrophil count (anc) \> 1800 cells/mm3 15. platelets ≥ 100,000 cells/mm3 16. hemoglobin \> 8.0 g/dl (note: the use of transfusion or other intervention to achieve hgb \> 8 g/dl is acceptable.) 17. pregnancy test must be negative for women of childbearing potential within 7 days prior to study entry 18. patient must sign study specific informed consent prior to study entry exclusion criteria: 1. prior surgical resection of any pancreatic malignancy 2. prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years 3. any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor. 4. prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields 5. severe, active comorbidity, defined as follows: 1. unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months 2. transmural myocardial infarction within the last 6 months 3. acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 4. chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration. 6. severe, uncorrectable hepatic insufficiency and/or coagulation defects due to liver failure 7. any evidence of distant metastases (m1) 8. pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
study of an online program to help parents talk with their tween children about health, gender, body-image, and relationships

Conditions: Parenting; Parent-Child Relations; Communication

Summary: the goal of this study is to learn if media aware parent - tween, an online program for parents of children ages 9-12, helps parents have effective conversations with their child about health and media.

parent-child pairs (n=300 pairs) will be recruited to participate in a randomized controlled trial. parent consent and parent permission and youth assent will be sought. participant pairs will be randomized into one of two study arms: intervention and active control. all participants will complete a web-based pre-test questionnaire. youth and parents will then receive access to their randomly assigned resource. approximately four weeks after completing the pre-test questionnaire, all participants will complete a web-based post-test questionnaire.

Eligibility criteria:
inclusion criteria: * the adult must be the legal guardian of a child ages 9 to 12 years old. * the parent must be able and willing to receive email and text communication as part of the study. * the parent-child pair must have access to a smartphone with internet connection as the resource review will be completed online in a format that is best viewed on a smartphone. * the parent-child pair must be fluent in english as the study materials are written in english. * the parent must indicate that they will give the child participant privacy to complete the questionnaires. * both the adult and child must agree to participate. exclusion criteria: * only one parent-child pair per family may participate in the study. if the parent has more than one child aged 9 to 12 that is willing to participate, the parent will be prompted to select the child participant based on the following: if the parent's last name begins with a letter from a to m, select the youngest eligible child willing to participate or if the parent's last name begins with a letter from n to z, select the oldest eligible child willing to participate. * in an effort to ensure diversity in parent gender and race/ethnicity, not all eligible pairs who are interested in participating will be enrolled in the study.

Keywords: preadolescent health media literacy parent-child communication gender stereotypes body-image puberty sexual health relationship health
esprit study in hypogonadal men

Conditions: Hypogonadism

Summary: observational study with androgel®, testosterone 1% gel therapy (esprit) in hypogonadal men in the community over 6 months.

the objective of this study was to evaluate the efficacy and safety of androgel (testosterone gel) 1% following administration in community dwelling men with hypogonadism. the percent change from baseline to month 6 in aging male symptom (ams) assessment was the primary endpoint. secondary endpoints were changes from baseline to month 6 in international index of erectile dysfunction (iief), multidimensional fatigue inventory (mfi), and body mass index (bmi) assessments.

Eligibility criteria:
inclusion criteria 1. male patients \>= 18 years of age 2. hypogonadism not previously treated with testosterone 3. testosterone deficiency confirmed clinically and biochemically 4. being prescribed androgel® 1% in accordance with the local summary of product characteristics exclusion criteria 1. according to the contra-indications, 2. unwilling or unable to sign informed consent form

Keywords: male hypogonadism
app for acute pain service in major surgery

Conditions: Mobile Applications; Pain, Postoperative; Smartphone; Patient Satisfaction

Summary: the app will be installed on the patient's smartphone before surgery. patients will receive reminders to record their pain intensity and opioid-related side effects at the pre-determined time points until at least 2 days after surgery. the patient's compliance with the reminders will be assessed. on the second postoperative day, their satisfaction with pain control and app usage will be evaluated. patients can also provide feedback on any issues they have encountered with the app during the study period.

following admission, the application will be installed on the enrolled patient's smartphone prior to surgery, and the patient will be instructed on the content of the program and how to use it. educational videos within the app about postoperative pain control will be introduced to the patient at this time. at the pre-determined time points, until at least 2 days post-operatively, the patient will be reminded of the assessment via an alarm function and will enter post-operative pain intensity using an 11-point numeric rating scale or verbal rating scale and the presence of opioid-related side effects into the application. if a patient responds to the alarm 2 or more times per day, they will be considered to be compliant. postoperative opioid consumption using patient-controlled analgesia and the amount of rescue analgesics will be assessed. patients will be assessed with a survey on postoperative day 2 for overall satisfaction with pain control and usage of the application. patients will also be able to provide feedback via the application or research staff on any errors or inconveniences they may have experienced while using the application throughout the study.

Eligibility criteria:
inclusion criteria: * adult patients aged 19 to 70 years who are scheduled for regular major surgery * american society of anesthesiologists (asa) physical status classification i or ii * patients who are using a smartphone and are not expected to have any restrictions on application use exclusion criteria: * unable to communicate * patients under the age of 19 and over the age of 70 * patients who, in the opinion of the investigator or study staff, are not appropriate for this study
simultaneous lengthening of bilateral femora and tibiae in achondroplastic patients

Conditions: SHOX Gene With Short Stature

Summary: the purpose of this study is to determine whether lengthening of both the tibiae and femora in achondroplastic patients is safe and provides reproducible outcome.


Eligibility criteria:
inclusion criteria: * achondroplasia, first lengthening period exclusion criteria: * previous lengthening

Keywords: lengthening
efficacy of a web-based alcohol intervention for high school students

Conditions: Underage Drinking

Summary: this study evaluates the efficacy of the echeckup to go as an intervention to reduce underage drinking and the associated negative consequences among high school seniors. the aim of this project is to provide a brief, low cost intervention that can be easily disseminated as a school-based intervention to address this important public health problem.


Eligibility criteria:
inclusion criteria: * senior enrolled in high school sites exclusion criteria: * none
effect of addition of dexmedetomidine during ultrasound guided bilateral single shot erector spinae plane block in patients undergoing posterior lumbar interbody fusion under general anesthesia

Conditions: Double Level Lumbar Spondylolisthesis (L3-L5); Posterior Lumbar Interbody Fusion (PLIF); Lumbar Fixation Surgery

Summary: posterior lumbar interbody fusion (plif) is the management of choice in double level lumbar (l) spondylolisthesis (l3-l5) after ineffective conservative treatment. we evaluated bilateral ultrasound (us)-guided single shot erector spinae plane (esp) block at the level of lumbar 3 (l3) vertebra with or without dexmedetomidine (dex).

objectives: posterior lumbar interbody fusion (plif) is the management of choice in double level lumbar (l) spondylolisthesis (l3-l5) after ineffective conservative treatment. we evaluated bilateral ultrasound (us)-guided single shot erector spinae plane (esp) block at the level of lumbar 3 (l3) vertebra with or without dexmedetomidine (dex). methods: a prospective controlled randomized, double-blind study comparing two groups of patients; each group included 20 patients of double level spondylolisthesis (l3-l5) scheduled for (plif) under general anesthesia combined with bilateral us-guided esp single shot block at (l3). group i received 20 ml of 0. 25% bupivacaine plus one ml normal saline bilaterally. group ii received 20 ml of 0.25% bupivacaine with supplementation of 1 ml containing 100µg dexmedetomidine bilaterally. post-anesthesia care unit (pacu) length of stay, the total dose of postoperative analgesics need, postoperative visual analogue score (vas) at 1h, 6h, 12h, and 24 h after the operation and postoperative complications which related to block or opioids were recorded. esp block at combined with (dex) is a safe, effective block with no complications. addition of 100µg dex to preoperative esp block provided good postoperative opioid-sparing analgesia, facilitated the early emergence and shortened the length of stay in the pacu during (plif) for double level spondylolisthesis (l3-l5).

Eligibility criteria:
inclusion criteria: * belonged to the american society of anesthesiologists (asa) physical status i or ii * either sex * aged 18-60 years * body mass index less 35 kg/m2 * complaining from double level lumbar spondylolisthesis (l3-l5) * scheduled for elective surgical intervention aimed at lumbar spine fixation by plif - under general anesthesia. exclusion criteria: * obesity (body mass index \> 35 kg/m2) * infection of the skin at the site of the needle puncture * allergies to either of the study drugs * bleeding disorder * and recent use of opioid.

Keywords: erector spinae dexmedetomidine ultrasound lumbar interbody fusion spondylolisthesis
malnutrition assessment with bioelectrical impedance analysis in gastric cancer patients undergoing multimodal treatment

Conditions: Gastric Cancer; Gastric Adenocarcinoma; Malnutrition; Cachexia

Summary: the aim of this single-arm prospective, multicenter, cross-sectional study is to evaluate the nutritional status and body composition on tumor regression grade with bioelectrical impedance analysis in gastric cancer patients undergoing multimodal treatment. results of this study will reveal whether nutritional status and body composition assessment based on bioelectrical impedance analysis will become a validated and objective tool to support clinical decisions in gastric cancer patients undergoing multimodal treatment.

up to 20% of gastric cancer patients experience unintentional loss of their pretreatment body weight. malnutrition contributes to increased morbidity, higher risk of perioperative complications and systemic toxicity. a standardized approach to evaluate the nutritional status of gastric cancer patients is yet to be established. bioelectrical impedance analysis is a non-invasive technique estimating changes in body composition over time. 125 patients with locally advanced gastric adenocarcinoma scheduled for multimodal treatment will be included in the study. four consecutive nutritional status assessments will be performed throughout the treatment.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. histologically confirmed gastric adenocarcinoma (or undifferentiated carcinoma) 3. stage ii - iii disease (ct2 cn+ and ct3-t4 cn+/-) based on the 8th edition of tnm classification 4. qualification for multimodal treatment by the decision of the multidisciplinary tumor board exclusion criteria: 1. early gastric cancer (ct1n0-3m0) scheduled for endoscopic treatment by multidisciplinary team 2. gastric stump carcinoma 3. distant metastasis 4. upfront surgery 5. other malignancies 6. contraindications to bioelectrical impedance analysis (e.g., implanted cardiac devices, metal implants or pregnancy)

Keywords: gastric cancer bioelectrical impedance analysis body composition nutritional status malnutrition cachexia multimodal treatment tumor regression grade
dic markers and thrombin generation parameters in patients on ecmo support: a pilot study

Conditions: Extracorporeal Circulation; Complications; Extracorporeal Membrane Oxygenation Complication

Summary: to study the correlation between novel dic markers and thrombin generation parameters with thrombotic and hemorrhagic complications of patients on ecmo support.


Eligibility criteria:
inclusion criteria: * age ≧ 18; and * admitted to the mixed medical-surgical intensive care units of queen mary hospital or tuen mun hospital in hong kong; and * require either veno-arterial (va) or veno-venous (vv) extracorporeal membrane oxygenation (ecmo) support. exclusion criteria: * patients who are on central va-ecmo support; or * patients with missing clinical data; or * patients with pre-existing thromboembolism requiring long term anticoagulation prior to ecmo cannulation; or * post-operative admissions

Keywords: ecmo thrombosis haemorrhage